Description and Brand Names

US Brand Name

Descriptions

Dinoprostone works by causing the cervix to thin and dilate (open) and the uterus to contract (cramp) the way it does during labor.

Dinoprostone may also be used for other purposes as determined by your doctor.

Dinoprostone is to be administered only by or under the immediate care of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, dinoprostone is used in certain patients with the following medical condition:

Unusual increase in bleeding of the uterus after delivery (postpartum hemorrhage)

This product is available in the following dosage forms:

Tampon

Suppository

Gel/Jelly

Insert, Extended Release

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pregnancy

Information about this dinoprostone-vaginal-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Anemia (or history of)—Dinoprostone, when used in doses that stimulate the uterus to contract, may result in loss of blood in some patients that may require a blood transfusion

Asthma (or history of, including childhood asthma) or

Lung disease—Dinoprostone may cause narrowing of the blood vessels in the lungs or narrowing of the lung passages, especially when it is used in doses that stimulate the uterus to contract

Epilepsy (or history of)—Rarely, seizures have occurred with dinoprostone when it is used in doses that stimulate the uterus to contract

Glaucoma—Rarely, the pressure within the eye has increased and constriction of the pupils has occurred during the use of medicines like dinoprostone; this may also be a problem with dinoprostone when it is used in doses that stimulate the uterus to contract

Heart or blood vessel disease (or history of) or

High blood pressure (or history of) or

Low blood pressure (history of)—Dinoprostone may cause changes in heart function or blood pressure changes; two patients with a history of heart disease had heart attacks when dinoprostone was used in doses that stimulated the uterus to contract

Kidney disease (or history of) or

Liver disease (or history of)—The body may not remove dinoprostone from the blood stream at the usual rate, which may make the dinoprostone work longer or cause an increased chance of side effects, especially when dinoprostone is used in doses that stimulate the uterus to contract

Problems during delivery, history of or

Surgery of uterus (history of) or

Unusual vaginal bleeding—There is an increased risk of problems occurring with dinoprostone when it is used in doses that stimulate the uterus to contract

Proper Use

After dinoprostone is given, you will need to lie down for 10 minutes to 2 hours so that the medicine can be absorbed. The length of time you must remain lying down will depend on what form of the medicine you are using.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For cervical dosage form (gel):

To thin and widen the opening of the cervix just before labor:

Adults and teenagers—Your doctor will insert 0.5 milligram (mg) (one application) of dinoprostone into the canal of your cervix. You should remain lying on your back for at least ten to thirty minutes after it has been applied.

For vaginal dosage form (gel):

To cause the uterus to contract for labor:

Adults and teenagers—Your doctor will insert 1 milligram (mg) (one applicatorful) of dinoprostone into your vagina. You should remain lying on your back for at least thirty minutes after it has been applied. You may need another dose of 1 to 2 mg six hours after the first dose.

For vaginal dosage form (suppositories):

To cause the uterus to contract to abort a pregnancy:

Adults and teenagers—Your doctor will insert 20 milligrams (mg) (one suppository) into your vagina every three to five hours as needed. You should remain lying on your back for at least ten minutes after it has been inserted.

For vaginal dosage form (system):

To thin and widen the opening of the cervix just before labor:

Adults and teenagers—Your doctor will insert 10 milligrams (mg) (one system) into your vagina. You should remain lying on your back for at least two hours after it has been inserted.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

This procedure may still result in some effects, which occur after the procedure is completed, that need medical attention. Check with your doctor if any of the following side effects occur:

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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